FDA UDI
In Commercial Distribution
🇺🇸 United States
JETSTREAM XC
DI: 00616258005157
·
Model: 112266-001
·
Bayer Healthcare LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- JETSTREAM XC
- Primary DI
- 00616258005157
- Version / Model
- 112266-001
- Catalog Number
- 112266
- Company Name
- Bayer Healthcare LLC
- Labeler DUNS
- 079415061
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-10-09
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- d6cee86b-4078-41ce-854b-35082b5bd276
Device Description
JETSTREAM XC 2.4MM, FG PKG
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MCW | Catheter, Peripheral, Atherectomy | Cardiovascular | 870.4875 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58171 | Atherectomy/thrombectomy rotational catheter | A sterile flexible tube designed for the percutaneous, transluminal disruption and removal of atheroma and clotted blood (i.e., a thrombus or thromboembolus) or other formed elements causing acute to chronic vascular obstruction in native and stented blood vessels, native and synthetic bypass, or haemodialysis access grafts, through a mechanical rotational action intended to shatter/erode the obstruction and aspirate debris for collection. It typically consists of a catheter with a rotating head with a magnetic power transmission provided by a connected control unit; ancillary device such as catheter guidewires, sterile covers and collecting bags may be included. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00616258005157 | GS1 |
Customer Contacts
- Phone
- 763-780-4555
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Gauge | 7 | French |